Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
- Conditions
- Influenza
- Interventions
- Biological: Influenza virus vaccine (Pediatric formulation)
- Registration Number
- NCT00836953
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.
To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months
- Detailed Description
The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Group Influenza virus vaccine (Pediatric formulation) Participants received 2 doses of Fluzone® vaccine
- Primary Outcome Measures
Name Time Method Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination Day 0 to 3 post-vaccination Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
- Secondary Outcome Measures
Name Time Method